Abstract
Background: Measure of serum 17β-Estradiol is essential to understand physiology, development and health of reproductive processes in both sexes. Commercially immunoassays are not enough sensitive and accurate to assess low concentrations of E2. Purpose of this study was to compare a new sensitive immunoassay for estradiol measurement with respect to method current in our laboratory and to evaluate the performance of the new method. Methods: Four pools of patient sera with E2 concentrations close to clinical decision values were prepared. To test the repeatability of new method the 5x5 protocol was used and CVs were calculated. To evaluate the performance of new method, 50 samples with E2 concentrations covering the whole measurable interval were selected and assayed. Linearity dilution, LoB (Limit of Blank) and LoD (Limit of Detection) were determined. Results: The new assay showed good total repeatability demonstrated by low CV values, and good linear relationship with respect to current method (R=0.9926) as demonstrated by linear regression. Non-parametric regression showed for the new method a slight constant and proportional systematic error that, however, resulted not significant from difference plot analysis, with a general tendency to overestimate results for the current method. Performances of the new method resulted acceptable within the maximum admissible error derived from the literature, and a good linearity over a wide range of dilutions was showed. LoD value confirmed an amelioration in measurement of low estradiol. Conclusion: In conclusion, sensitive assay is suitable to replace the method used in our laboratory with significant improvement in the measurement of low serum estradiol levels.
Highlights
Measure of serum 17β-Estradiol is essen to understand physiology, development and health of repr e processes in both sexes
Since the new method was already validated by the manufacturer following Approved Guideline from Clinical and Laboratory Standard Ins e W[19,20,21,22,23,24], a rapid protocol was carried out to verify what was declared
Limit of Blank (LoB) and Limit of Detection (LoD) calcula (A) The LoB value was assessed by using the formula described in Materials and Methods Results are expressed as pg/mL; (B) The LoD value was assessed by using the formula described in Materials and Methods Results are expressed as pg/mL
Summary
The aims of the present study are (i) The comparison between the new method Beckman Coulter Access e Estradiol assay and the current method Beckman Coulter Access Estradiol assay, (ii) The evalua of performance of the new method in terms of repeatability and acceptability
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
